LYT-100 in Post-acute COVID-19 Respiratory Disease

Phase 2 Terminated 185 enrolled PureTech Clinipace Worldwide · collab Novotech (Australia) Pty Limited · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is being conducted in two parts, A and B. Part A is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications. Part B is an Open Label Extension (OLE) study for patients who complete Part A.

Timeline

Start: 2020-12-11
Primary completion: 2022-06-28
Completion: 2022-07-18

Outcome

Missed primary endpoint

Stopped: “Part A of the study was completed; Part B of the study was terminated”

registry analysis (superiority test); Placebo; p = 0.698; Mixed Models Analysis NCT04652518 ↗

release “PureTech Reports Results from Phase 2 Study of LYT-100-COV in Post-Acute "Long" COVID with Respiratory Complications No treatment effect observed in this patient population” puretechhealth.com ↗

Publications

Kulkarni T, Santiaguel J, Aul R, Harnett M, Krop J, Chen MC, Graham CS, Maher TM. Deupirfenidone (LYT-100) in post-acute sequelae of SARS-CoV-2 with respiratory complications. ERJ Open Res. 2025 Jul 21;11(4):01142-2024. doi: 10.1183/23120541.01142-2024. eCollection 2025 Jul.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deupirfenidone	Unknown	750 mg	Oral